8/11/2019 Chapter 02-drug approval process

http://slidepdf.com/reader/full/chapter-02-drug-approval-process 1/3

Kee: Pharmacology, 8th Edition

Chapter 2: The Drug Approval Process

Downloadale Key Points

• The U.S. Food and Drug Administration (FDA) averages 23 drug approvals per year.

• The FDA Critical ath !nitiative is a national strategy "to drive innovation in the

scienti#ic processes through $hich medical products are developed% evaluated% andmanu#actured.&

D!"# $TA%DA!D$ A%D &E#'$&AT'(%

• The com'ination o# drug discovery and manu#acturing taes 2 to 2* years% $ith a cost o# 

more than + 'illion. ,nly a small percentage o# drugs are approved.

• The United States Pharmacopeia National Formulary (USP-NF) is the authoritativesource #or drug standards.

• Drugs included in the US-F have met high standards #or therapeutic use% patient

sa#ety% /uality% purity% strength% pacaging sa#ety% and dosage #orm.

• The International Pharmacopeia% #irst pu'lished in 01 'y the orld ealth

,rgani4ation (,)% provides a 'asis #or standards in strength and composition o# drugs#or use throughout the $orld. Through #ederal legislation% the pu'lic is protected #romdrugs that are impure% to5ic% ine##ective% or not tested 'e#ore pu'lic sale.

• The Food% Drug% and Cosmetic Act o# 036 empo$ered the FDA to ensure drug sa#ety 'y

monitoring and regulating the manu#acture and mareting o# drugs. !t is the FDA7s

responsi'ility to ensure that all drugs are tested #or harm#ul e##ects% have la'els $ithaccurate in#ormation% and enclose detailed literature in the drug pacaging that e5plainsadverse e##ects.

• The Durham-umphrey Amendment to the Food% Drug% and Cosmetic Act o# 036

distinguished 'et$een drugs that can 'e sold $ith or $ithout prescription and those thatshould not 'e re#illed $ithout a ne$ prescription.

• The 8e#auver-arris Amendment o# 092 tightened controls on drug sa#ety% especially

e5perimental drugs% and re/uired that adverse reactions and contraindications must 'ela'eled and included in the literature.

• The Controlled Su'stances Act o# 0:*% designed to remedy the escalating pro'lem o#

drug a'use% included several provisions; () the promotion o# drug education and research

into the prevention and treatment o# drug dependence% (2) the strengthening o#en#orcement authority% (3) the esta'lishment o# treatment and reha'ilitation #acilities% and(<) the designation o# schedules% or categories% #or controlled su'stances according toa'use lia'ility.

• Schedule ! drugs are not approved #or medical use= schedule !! through > drugs have

accepted medical use. The a'use potential and e5tent o# physical and psychologicaldependence are greatest $ith schedule ! drugs. This dependency decreases as one movesthrough the schedule% $ith schedule > drugs having only limited a'use potential.

Copyright ? 2*1% 2*2% 2**0% 2**9% 2**3% 2***% 00:% 003 'y Saunders% an imprint o# @lsevier !nc.

8/11/2019 Chapter 02-drug approval process

http://slidepdf.com/reader/full/chapter-02-drug-approval-process 2/3

Do$nloada'le 8ey oints 2-2

• The ,rphan Drug Act o# 063 promoted the development and manu#acture o# drugs used

to treat rare diseases through () #ederal #unding o# grants and contracts to per#ormclinical trials o# orphan products% (2) 1* ta5 credit #or costs o# clinical testing% and (3)e5clusive right to maret the drug #or : years #rom the mareting approval date.

• There are #ive provisions o# the 00: Food and Drug Administration Boderni4ation Act;

() revie$ and use o# ne$ drugs is accelerated= (2) drugs can 'e tested in children 'e#oremareting= (3) clinical trial data are necessary #or e5perimental drug use #or serious orli#e-threatening health conditions= (<) drug companies are re/uired to give in#ormation on"o##-la'el& drugs (nonFDA-approved drugs) and their uses and costs= and (1) drugcompanies that plan to discontinue drugs must in#orm health pro#essionals and patients atleast 9 months 'e#ore stopping drug production.

• The ealth !nsurance orta'ility and Accounta'ility Act (!AA) o# 2**3 set the

standards #or the privacy o# individually identi#ia'le health in#ormation.

• @ssential components o# the 2** atient rotection and A##orda'le Care Act include ()

/uality% a##orda'le health care #or all Americans= (2) improved /uality and e##iciency o#health care= (3) prevention o# chronic disease and improved pu'lic health= (<) improved

access to innovative medical therapies% and (1) community living services and supports.

%"!$E P!ACT'CE ACT$

• @very state has its o$n la$s regarding drug administration 'y nurses= generally% nurses

cannot prescri'e or administer drugs $ithout a health care provider7s order.

• !n a civil court% the nurse can 'e prosecuted #or giving the $rong drug or dosage% omitting

a drug dose% or giving the drug 'y the $rong route.

CA%AD'A% D!"# !E#"&AT'(%

• !n Canada% the ealth rotection ranch% Department o# ational ealth and el#are% is

responsi'le #or the administration o# the t$o acts that are the #oundation o# national drugla$s.

• The manu#acture% distri'ution% and sale o# drugs (e5cept narcotics) are controlled 'y the

Canadian Food and Drug Act% amended in 013.

• The manu#acture% distri'ution% and sale o# narcotic drugs are controlled 'y the 009

Controlled Drugs and Su'stances Act.

•  onprescription drugs are administered 'y the pharmacy acts o# the respective Canadian

 provinces that identi#y the place and conditions o# sale.

'%'T'AT')E$ T( C(*+AT D!"# C("%TE!E'T'%#

• Bedication sa#ety may 'e a##ected 'y counter#eit drugs and adulterated prescription

drugs.

• Use o# counter#eit and adulterated prescription drugs is on the rise.

• The role o# the nurse is critical in consumer education= nurses must advise patients to

report any di##erences in taste or appearance o# a drug or in its pacaging.

Copyright ? 2*1% 2*2% 2**0% 2**9% 2**3% 2***% 00:% 003 'y Saunders% an imprint o# @lsevier !nc.

8/11/2019 Chapter 02-drug approval process

http://slidepdf.com/reader/full/chapter-02-drug-approval-process 3/3

Do$nloada'le 8ey oints 2-3

D!"# %A*E$

• @ach drug may have several di##erent names; the chemical name% the generic name% and

the trade or 'rand name.

• The chemical name o# a drug descri'es the chemical structure o# the drug.• The generic name is the o##icial% nonproprietary name #or the drug.

• The generic name al$ays 'egins $ith lo$ercase letters.

• Eeneric drugs must 'e approved 'y the FDA 'e#ore they can 'e mareted.

• Eeneric drugs have the same active ingredients as 'rand-name drugs.

• Some generic drugs have inert #illers and 'inders that may result in variations o# drug

e##ectiveness.

• The 'rand (trade) name% also no$n as the proprietary name% is chosen 'y the drug

company and is usually a registered trademar o$ned 'y that speci#ic company.

• rand names al$ays 'egin $ith a capital letter.

D!"# !E$("!CE$

• Bany drug re#erences are availa'le% including nursing te5ts that identi#y related nursing

interventions and areas #or health teaching.

•  American Hospital Formulary Service (AHFS) Drug Inormation is pu'lished 'y the

American Society o# ealth-System harmacists in ethesda% Baryland. !t providesaccurate and complete drug in#ormation on nearly all prescription drugs mareted in theUnited States.

• The United States Pharmacopeia!Drug Inormation (USP-DI) is a three-volume set that

is availa'le in most hospitals and pharmacies and supplies monthly supplements. The #irst

t$o volumes% >olumes !A and !% provide drug in#ormation #or the health care provider.• Bedlinelus is a service o# the U.S. ational i'rary o# Bedicine. Availa'le at

http;GG$$$.nlm.nih.govGmedlineplusGdrugin#ormation% it o##ers e5tensive in#ormation on prescri'ed drugs as $ell as her's and supplements% inde5ed 'y generic and 'rand names.

Copyright ? 2*1% 2*2% 2**0% 2**9% 2**3% 2***% 00:% 003 'y Saunders% an imprint o# @lsevier !nc.